Biostatistician

About the Role

The Biostatistician II serves as a pivotal contributor to our clinical research programs, bridging the gap between statistical design and execution. This role is designed for a professional who possesses a working knowledge of all related processes and the confidence to independently lead studies while supporting broader analysis efforts. The position exists to ensure the delivery of high-quality documents that drive sponsors' research initiatives forward.

You will collaborate cross-functionally with the programming team, yet you will also be expected to independently contribute to statistical deliverables and perform rigorous quality reviews. The ideal candidate brings strong applied SAS skills, including expertise in TFLs, inferential analyses, and randomization. While experience with Phase 1 clinical trials is highly desirable—particularly regarding first-in-human and dose-escalation studies involving PK/PD data and early safety endpoints—the role also offers opportunities to oversee nonclinical projects and mentor junior team members.

In this capacity, you will act as a central point of contact for assigned Biostatistics teams, extended internal project teams, and clients. Your day-to-day involves reviewing protocols, generating randomization schedules, and developing Statistical Analysis Plans (SAPs) alongside table, figure, and listing (TFL) shells. You will represent the Biostatistics department in client and inter-departmental meetings, ensuring that all work aligns with global regulatory requirements (FDA, EMA, ICH, GCP) and maintains the highest standards of accuracy and compliance.